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Pioglitazone vs. Placebo in Association With Pegylated Interferon and Ribavirin in HCV Patients With Insulin Resistance (PEGLIST C)

This study has been terminated.
(Suspension of use of medicine containing Pioglitazone by French regulatory agency)
Sponsor:
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ( French National Agency for Research on AIDS and Viral Hepatitis )
ClinicalTrials.gov Identifier:
NCT00927290
First received: June 22, 2009
Last updated: January 23, 2017
Last verified: January 2017
  Purpose
The purpose of this study is to test whether the correction of insulin resistance with pioglitazone, will improve the response to antiviral treatment.

Condition Intervention Phase
Chronic Hepatitis C Insulin Resistance Drug: Pioglitazone Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
Official Title: ANRS HC 22, PEGLIST-C, Multicenter, Randomized Controlled Trial of Pioglitazone vs. Placebo in Association With Pegylated Interferon and Ribavirin in Patients With Chronic Hepatitis C, Non 2 or 3 Genotypes and Insulin Resistance

Resource links provided by NLM:


Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ( French National Agency for Research on AIDS and Viral Hepatitis ):

Primary Outcome Measures:
  • Decrease in the HOMA score below 2 after 4 months of treatment with pioglitazone or placebo(at W16). The efficiency is defined as a higher proportion of subjects with HOMA <2 in the pioglitazone group than in the group treated with placebo pioglitazone. [ Time Frame: W16 ]

Secondary Outcome Measures:
  • Kinetics of decrease in viral response to pegylated interferon. Early virological response rates. Rates of sustained virological response. Effect on steatosis [ Time Frame: EVR at W16 and W28 SVR at W88 ]

Enrollment: 40
Actual Study Start Date: December 3, 2009
Study Completion Date: July 6, 2012
Primary Completion Date: July 6, 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Pioglitazone, 16 weeks before and during antiviral combination therapy
Drug: Pioglitazone
Pioglitazone, 45 mg QD (30 mg QD the first month)
Placebo Comparator: 2
Pioglitazone placebo, 16 weeks before and during antiviral combination therapy
Drug: Placebo
Placebo 45 mg QD (30 mg QD the first month)

Detailed Description:
In patients infected with genotypes 1, 4, 5 and 6, the response rate to antiviral therapy remains suboptimal (less than one in two patients have a sustained virological response), which justifies the search for strategies optimizing the results of antiviral therapy. Some factors associated with non response have been identified. Among the modifiable factors, numerous series have shown that insulin resistance adversely impacts the rate of sustained virological response. The aim of this study is to determine whether the pharmacological correction of insulin resistance through therapy with glitazones restores higher rates of viral eradication and to determine the impact on the kinetics of viral response. Patients will be randomized to receive pioglitazone or placebo starting 4 months before initiating pegylated interferon and ribavirin and continued throughout the whole antiviral treatment period.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years old or older
  • Chronic HCV infection documented by PCR with genotype HCV-1, 4, 5 or 6
  • Naive Patient(never treated with antivirals for HCV)
  • HOMA score higher than 2.5
  • Patient for which the investigator decided to start antiviral treatment for chronic hepatitis C

Exclusion Criteria:

  • Cardiovascular disease: heart failure stage NYHA II, III or IV, unstable angina, myocardial infarction in the previous year, cardiac surgery or stroke
  • Alcohol consumption exceeding 40 g / day
  • Decompensated liver disease: Child-Pugh B 8 or higher, or one of the following : bilirubin over 35 mol / L, TP below 50%, ascites, encephalopathy
  • Hepatocellular carcinoma or any other neoplasm (except if in remission for > 5 years)
  • Other documented chronic liver disease
  • Insulin treated diabetes
  • HBV or HIV co-infection infection confirmed
  • Thrombocytopenia below 50 000/mm ³; neutropenia below 750/mm ³ or hemoglobin below 11 g / dL
  • Drug-induced steatosis(tamoxifen, glucocorticosteroids, amiodarone, tetracyclines).
  • Bone marrow or solid organ transplantation
  • Pregnancy or breastfeeding, or desire for pregnancy during the study period.
  • Patients under legal protection or unable to express their consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927290

Locations
France
Hôpital Pitié Salpêtrière, Service d'hépatogastroentérologie
Paris, France, 75013
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Investigators
Principal Investigator: Vlad RATZIU, MD, PHD Hôpital Pitié--Salpêtrière, 83 Bd de l'Hôpital 75651 Paris cedex 13, FRANCE
  More Information

Responsible Party: French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier: NCT00927290     History of Changes
Other Study ID Numbers: 2008-006225-14
Study First Received: June 22, 2009
Last Updated: January 23, 2017

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ( French National Agency for Research on AIDS and Viral Hepatitis ):
hepatitis C; insulin resistance; glitazones; pioglitazone; steatosis; viral kinetics; antiviral response

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Insulin Resistance
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pioglitazone
Insulin
Interferons
Ribavirin
Antiviral Agents
Hypoglycemic Agents
Physiological Effects of Drugs
Antineoplastic Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 23, 2017